Secondary Prevention of Schizophrenia. A randomized controlled trial

精神分裂症是一种慢性疾病，对个人、家庭和社会造成毁灭性后果。近年来，新的临床发现和假设表明，精神分裂症的二级预防（SPS）是可能的。尽管非典型抗精神病药（AN）和认知行为疗法（CBT）已被用于二级预防工作，但由于方法学的限制，预防效果仍然不确定，CBT和AN对有精神病前驱症状（PAR）风险的人的不同疗效尚不清楚。因此，prevention以高度严谨的方法学解决了以下主要研究问题：(1)临床管理和阿立哌唑联合（CM+ARI）对有精神病前驱症状（PAR）风险的人是否比CM和安慰剂联合（CM+PL）更有效？(2)认知行为疗法（CBT）治疗PAR是否比CM+PL更有效？(3) CBT治疗PAR的效果是否低于CM+ARI？在7个早期检测和干预中心，380名PAR将被招募，为期30个月，在12个月的平行组随机对照试验中，有三种研究条件[CM+ ARI， CM+PL（双盲），CBT（盲法评分）]。关于SPS的主要目标“预防/延迟向精神病的过渡”的积极预防结果将证明SPS是精神卫生保健的标准做法。此外，他们将表明CBT与AN相当有效。因此，PAR将受益于预防战略的选择。因此，PAR、其家庭和一般人群对SPS工作的接受、容忍和依从性可能会改善，精神卫生系统对精神分裂症负担、残疾和经济后果的影响可能会加强。

Schizophrenia is a chronic disease with devastating consequences for individuals, families and society. In recent years, new clinical findings and hypotheses suggested that secondary prevention of schizophrenia (SPS) may be possible. Although atypical neuroleptics (AN) and cognitive-behavioral therapy (CBT) have been used in secondary prevention efforts, due to methodological limitations the preventive effects remains uncertain and the differential efficacy of CBT and AN for persons at risk of being prodromally symptomatic for psychosis (PAR) is unknown. Therefore PREVENT addresses the following principal research questions with high methodological rigor: (1) Are clinical management and aripiprazole combined (CM+ARI) more effective in persons at risk of being prodromally symptomatic for psychosis (PAR) than CM and placebo combined (CM+PL)? (2) Is cognitive-behavioral therapy (CBT) more effective in PAR than CM+PL? (3) Is CBT not less effective in PAR than CM+ARI? At 7 early detection and intervention centers 380 PAR will be recruited over a 30-months period in a 12-months parallel group randomized controlled trial with three study conditions [CM+ ARI, CM+PL (double-blind), CBT (blinded ratings)]. Positive PREVENT results with regard to the primary aim of SPS “prevention/delay of transition to psychosis” will justify SPS as a standard practice in mental health care. Moreover, they will suggest that CBT is comparable effective to AN. Thus PAR will benefit from a choice of prevention strategies. Thereby acceptance, tolerance and compliance with SPS efforts in PAR, in their families and in the general population is likely to improve and the impact of the mental health system on burden, disability and economical consequences of schizophrenia might be strengthened.